Pv/ra/qm Executive Jo-221130-300215

1 day ago

Singapore RGF Full time

**Location**: Singapore

**Salary**: Open

**Industry**: Healthcare & Life Sciences

**Sub-industry**: Pharmaceuticals

**Function**: Healthcare R&D
**Job Description**:
**Our Client**:
Our client is one of the top leading pharmaceutical companies, with HQ in Japan. They have more than 5,000 employees and has grown into a company that can deliver their products to people in more than 80 countries around the world. Due to expansion of their Singapore office, they are actively looking for a PV/RA/QM Executive to join in their efforts.

**The Responsibilities**:

- Maintains current knowledge, ensures compliance, and communicates with the relevant global, regional, and local functions of the local regulatory requirements
- Review, process, and forwards safety events (pre-marketing and post-marketing) and/or other medically related information to Global PV and submits such safety events to the local health authority according to relevant global/local SOPs and local requirements
- Perform review of abstracts and full articles to identify safety information from literature source
- Support creation, management, and oversight of local RMP and all RMP-related PV activities.
- Support creation and management of local PSMF development
- Liaise with investigational site and reporter as necessary regarding safety issues
- Develop local PV training material and conduct PV training as per relevant SOPs
- Prepare, review, update and maintain PV clauses in all relevant agreements from PV perspective
- Manages and conducts oversight of Aggregate Report submission to the applicable local health authorities
- Perform reconciliation of safety information with relevant internal and external functions
- Supports audits and inspections, including external vendors and ensures execution of deviation and CAPA management
- Develop and maintain PV Business Continuity Plan in accordance with global SOPs
- Preparing registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in the local market
- Reviewing change requests and assess regulatory impact of product changes
- Reviewing proposed labelling for compliance with product branding, global/regional standards, and applicable regulations
- Prepare, maintain, and supervise implementation, including training of current applicable local, regional, and global SOPs to ensure compliance in the company as required
- Responsible for local operational quality matters including product hold and product recalls
- Support in addressing deviations, product complaints from customer to manufacturer, monitor the status until closure
- Manage outsourced activities to ensure vendors meet the applicable local and global standards

**The Requirements**:

- Minimum Bachelor's Degree in Pharmacy, Life Sciences or equivalent with 1 - 3 years' experience in PV and/or RA experience in Singapore Pharmaceutical Industry
- Possess a Pharmacist License in Singapore is preferred
- Strong organizational and process management skills
- Able to multitask and manage relations with internal and external stakeholders
- Teamwork and collaboration with cross functional teams

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